Enhancing Precise Perioperative Risk Surveillance: Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. The main questions are: Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care? And which submaximal cardiopulmonary exercise testing measure is better? Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test, then undergo surgery. Myocardial injury will be measured on postoperative days 0, 1, 2, and 3 (during and up to 3 days after surgery). These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test. If there is a relationship, this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: t
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• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Biological male or female, aged 45 years or older.

• In good general health as evidenced by medical history or diagnosed with metabolic equivalents (self-reported ability to climb 1 flight of stairs).

• Revised Cardiac Risk Index less than or equal to three.

• Willing to accept phlebotomy on operative day 0, 1, 2, and 3, as part of usual care.

• Scheduled for moderate to high-risk elective non-cardiac surgery with an expected 24-72 hour stay within 60 days of enrollment in the study.

Locations
United States
Connecticut
Yale University; Yale New Haven Hospital
RECRUITING
New Haven
Contact Information
Primary
Zyad J Carr, M.D.
zyad.carr@yale.edu
203-785-3689
Time Frame
Start Date: 2025-03-30
Estimated Completion Date: 2026-01
Participants
Target number of participants: 61
Treatments
Experimental: Submaximal cardiopulmonary exercise testing
Single arm design; selected participants will receive both usual care (Duke Activity Status Index) and submaximal cardiopulmonary exercise testing. All participants will receive high-sensitivity troponin measurements on operative day 1 and postoperative day 1,2,3
Related Therapeutic Areas
Sponsors
Leads: Yale University

This content was sourced from clinicaltrials.gov

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